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Hydroxyzine Pamoate 25 mg Capsule, 30-count — NDC 71205-483-30 (Billing 71205-0483-30)

by Proficient Rx LP · 30 CAPSULE in 1 BOTTLE

This is a package of 30 capsules of Hydroxyzine Pamoate 25 mg Capsule from Proficient Rx LP, marketed since Jul 1984 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 71205-0483-30
🏷️ FDA NDC (as labeled) 71205-483-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1145/unit — full pricing hub ↓
Main listing for product 71205-483 · Also comes in: 60 capsules 71205-483-60 90 capsules 71205-483-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 71205-483-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71205 labeler · 483 product · 30 package
Package marketed since
Oct 8, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 7120548330 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71205-483-30
Product NDC 71205-483
11-digit billing NDC 71205048330
NCPDP billing unit EA — each (per item)
RxCUI 995253
UNII M20215MUFR
Application # ANDA088496
SPL Set ID b098e287-e489-4cdc-9171-7daf50380c1c
Established class (EPC) Antihistamine
Mechanism of action Histamine Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1984-07-01
Route ORAL
Dosage form CAPSULE
Substance HYDROXYZINE PAMOATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 57200040200105
GPI class hydrOXYzine Pamoate
GCN Seq No 003731
GCN 13952
HICL code 001609
Ingredient (HICL) Hydroxyzine Pamoate
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name HYDROXYZINE PAM 25 MG CAP
FDB brand name Hydroxyzine Pamoate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003731
  • GCN: 13952
  • GPI-14 (Medi-Span): 57200040200105
  • HICL (First Databank): 001609
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 995253
Why two NDCs? The FDA registers this code as 71205-483-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71205-0483-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antihistamine class.

Pharmacologic class Antihistamine
Drug family (ATC) Diphenylmethane derivatives
How it works Histamine Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name HYDROXYZINE PAM 25 MG CAP Ingredient Hydroxyzine Pamoate
📗 Our plain-language guide HelloPharmacist
  • Taken by mouth, it's used for anxiety and tension, itching from allergic skin conditions like hives and eczema, and sedation around anesthesia. The injection has additional uses in...
  • It can. Drowsiness is the most common effect, though it often fades in a few days or with a lower dose. Don't drive or use dangerous machinery until you know how it affects you.
  • It's best not to. Hydroxyzine can strengthen alcohol, narcotics, barbiturates and other sedating drugs. Tell your prescriber about everything you take, since doses of some may need...
  • Can I drink alcohol or take other sedating medicines with it?
📖 Read our full Hydroxyzine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1145 $3.44 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71205-0483-30 You're viewing this Main listing 30 CAPSULE in 1 BOTTLE 2020-10-08 — Active
71205-0483-60 71205-483-60 60 CAPSULE in 1 BOTTLE 2020-10-08 — Active
71205-0483-90 71205-483-90 90 CAPSULE in 1 BOTTLE 2020-10-08 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 capsule in 1 bottle.
How does this package differ from NDC 71205-0483-60?
Both are Hydroxyzine Pamoate 25 mg Capsule — the drug itself is identical. This page's package is the 30-count one, while NDC 71205-0483-60 is the 60 capsules package.
What NDC number is used to bill for this package of Hydroxyzine Pamoate 25 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroxyzine Pamoate 25 mg 00115-1803-01 Amneal 100 capsules $0.064 AB Availability likely —
hydroxyzine pamoate 25 mg 00185-0674-01 Sandoz 100 capsules $0.064 AB Availability likely —
Hydroxyzine Pamoate 25 mg 00555-0323-02 Teva 100 capsules $0.064 AB Availability likely —
hydroxyzine pamoate 25 mg 00904-7065-61 Major 100 capsules $0.064 AB Availability likely —
hydroxyzine pamoate 25 mg 14539-0674-01 Heritage 100 capsules $0.064 AB Availability likely —
Hydroxyzine Pamoate 25 mg 50268-0398-50 AvPAK 50 capsules $0.064 AB Availability likely —
Hydroxyzine Pamoate 25 mg 60687-0696-01 American 100 capsules $0.064 AB Availability likely —
Hydroxyzine pamoate 25 mg 62135-0816-12 Chartwell 120 capsules $0.064 AB Availability likely —
Hydroxyzine Pamoate 25 mg 00615-8419-39 NCS 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 43063-0172-01 PD-Rx 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 43063-0406-01 PD-Rx 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 50090-4385-02 A-S 20 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 50090-4579-02 A-S 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 51407-0001-01 Golden 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 51655-0847-20 Northwind 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 55154-2337-00 Cardinal 10 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 61919-0880-15 Direct_Rx 15 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 63629-8874-01 Bryant 500 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 63629-9612-01 Bryant 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 67046-0281-03 Coupler 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 67046-2086-03 Coupler 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68071-2255-02 NuCare 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68071-3736-01 NuCare 100 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 68071-4915-03 NuCare 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68071-4954-03 NuCare 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68788-7767-01 Preferred 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68788-8119-01 Preferred 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 70518-0209-00 REMEDYREPACK 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 70518-1504-00 REMEDYREPACK 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71205-0087-15 Proficient 15 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71205-0123-15 Proficient 15 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71205-0433-30 Proficient 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mgthis 71205-0483-30 Proficient 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71205-0558-30 Proficient 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71335-0998-01 Bryant 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71335-1325-01 Bryant 20 capsules — AB Discontinued —
hydroxyzine pamoate 25 mg 71335-1714-01 Bryant 20 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71335-2187-01 Bryant 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71335-2751-01 Bryant 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71335-3003-01 Bryant 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71610-0217-30 Aphena 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71610-0747-30 Aphena 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71610-0773-30 Aphena 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71610-0883-30 Aphena 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 72162-1054-03 Bryant 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 72189-0009-30 Direct_Rx 30 capsules — AB Discontinued —
Hydroxyzine Pamoate 25 mg 76420-0920-01 Asclemed 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 82982-0032-30 Pharmasource 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 87441-0040-01 Unit 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 51655-0725-52 Northwind 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 87441-0087-01 Unit 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1984
On the market since
Jul 1984
📍
2026
Currently FDA-listed
42 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow / Pink
ShapeCapsule
Imprintbarr;323;25
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII D3741U8K7L
    A blue colorant derived from indigo dye. It's added to tablets and capsules to provide color identification and improve the appearance of the medication.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

16 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderBARR LABORATORIES INC
FDA applicationANDA088496 (ANDA)
Labeler code71205
First marketedJul 1984
Product typeHuman Prescription Drug
Portfolio1,729 products on file

More NDCs from Proficient Rx LP labeler code 71205

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 157 words ▾

INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol ® ) and barbiturates , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis.

Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies.

The physician should reassess periodically the usefulness of the drug for the individual patient.

⏱️ Dosage and Administration 163 words ▾

DOSAGE AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

⛔ Contraindications 102 words ▾

CONTRAINDICATIONS Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.

Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine pamoate is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication. Hydroxyzine is contraindicated in patients with known hypersensitivity to hydroxyzine products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.

⚠️ Warnings 29 words ▾

WARNINGS Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

🤒 Adverse Reactions 132 words ▾

ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine pamoate are usually mild and transitory in nature. Skin and Appendages Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports. Anticholinergic Dry mouth.

Central Nervous System Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

Cardiac System QT prolongation, Torsade de Pointes. In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole allergic reaction. Nervous System headache.

Psychiatric hallucination. Skin and Appendages pruritus, rash, urticaria.

🧓 Geriatric Use 145 words ▾

Geriatric Use A determination has not been made whether controlled clinical studies of hydroxyzine pamoate included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

The extent of renal excretion of hydroxyzine pamoate has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections. Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine pamoate and observed closely.

🆘 Overdosage 190 words ▾

OVERDOSAGE The most common manifestation of overdosage of hydroxyzine pamoate is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.

Hypotension, though unlikely, may be controlled with intravenous fluids and vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor action). Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous system depressant effects. Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes.

ECG monitoring is recommended in cases of hydroxyzine overdose. There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine.

However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

🧬 Clinical Pharmacology 132 words ▾

CLINICAL PHARMACOLOGY Hydroxyzine pamoate is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. Hydroxyzine pamoate is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally.

Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity.

Hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine pamoate's clinical effects are usually noted within 15 to 30 minutes after oral administration.

📦 How Supplied / Storage and Handling 125 words ▾

HOW SUPPLIED Hydroxyzine Pamoate Capsules USP (hydroxyzine pamoate, USP equivalent to hydroxyzine hydrochloride), 25 mg are available as light yellow opaque cap and pink opaque body filled with yellow powder, imprinted in black ink stylized “barr” over “323” on one piece and “25” on the other piece, packaged in bottles of 30 (NDC 71205-483-30), 60 (NDC 71205-483-60) and 90 (NDC 71205-483-90) capsules. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 Rev.

E 10/2019

📋 Description ~1 min read ▾

DESCRIPTION Hydroxyzine pamoate, USP is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula: C 21 H 27 ClN 2 O 2 •C 23 H 16 O 6 M.W. 763.27 Hydroxyzine Pamoate Capsules USP are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride.

In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. The 25 mg also contains anhydrous lactose. The 50 mg and 100 mg also contain lactose monohydrate.

The capsule shell ingredients for the 25 mg capsule are D&C red no. 28, D&C yellow no. 10, FD&C blue no.

1, FD&C red no. 40, FD&C yellow no. 6, gelatin, and titanium dioxide.

The 50 mg capsule shell contains D&C red no. 33, D&C yellow no. 10, FD&C yellow no.

6, gelatin, and titanium dioxide. The 100 mg capsule shell contains D&C red no. 28, D&C red no.

33, D&C yellow no. 10, FD&C blue no. 1, FD&C red no.

40, gelatin, and titanium dioxide. The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no.

1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol, and shellac glaze.

Structural Formula

⚠️ Precautions ~2 min read ▾

PRECAUTIONS THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine, their dosage should be reduced. Since drowsiness may occur with use of the drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine pamoate.

Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased. QT Prolongation/Torsade de Pointes (TdP) Cases of QT prolongation and Torsade de Pointes have been reported during postmarketing use of hydroxyzine. The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use).

Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias. Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).

Acute Generalized Exanthematous Pustulosis (AGEP) Hydroxyzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous erythema. Inform patients about the signs of AGEP, and discontinue hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which hydroxyzine may be used to treat, or any other sign of hypersensitivity.

If signs or symptoms suggest AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered. Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-sensitivity. Geriatric Use A determination has not been made whether controlled clinical studies of hydroxyzine pamoate included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. The extent of renal excretion of hydroxyzine pamoate has not been determined.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections. Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine pamoate and observed closely.

🍼 Nursing Mothers 28 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

📄 Package Label / Principal Display Panel 27 words ▾

Package/Label Display Panel HydrOXYzine Pamoate Capsules USP 25 mg 30s Label Text NDC 71205- 483 -30 HydrOXYzine Pamoate Capsules USP 25 mg Rx only 30 CAPSULES 71205-483-30

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Hydroxyzine Pamoate — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hydroxyzine Pamoate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.91M
Claims incl. refills
378.4K
Beneficiaries
207.9K
Spend / beneficiary
$18.79
Spend / claim
$10.33
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 capsules (71205-0483-60), 90 capsules (71205-0483-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71205-0481-30 · Proficient 71205-0484-30 · Proficient →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.